AUSTRALIA’S college of gynaecologists and obstetricians has backed the use of traditional pelvic mesh “slings” for incontinence in women despite conceding failure can lead to “intractable” and permanent complications and have “severe effects” on quality of life.
In response the Australian Pelvic Mesh Support Group said all mesh devices should be banned.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) backed traditional midurethral “slings”, such as the Tension-free Vaginal Tape (TVT), in a position statement this week after growing global outrage from women about pelvic mesh surgery for both incontinence and prolapse.
The statement was released a month before the expected start of a landmark class action by 450 Australian women who experienced serious complications after they were implanted with Johnson & Johnson pelvic mesh devices, including the TVT midurethral sling for incontinence.
RANZCOG conceded more recent single incision incontinence mesh slings – many already withdrawn from the Australian market after women experienced serious complications - should only be performed “within a properly-conducted clinical trial”.
In some women these long term adverse outcomes have had severe effects on everyday activities and their quality of life.Royal Australian and New Zealand College of Obstetricians and Gynaecologists
But it blamed “media attention” on mesh use for pelvic organ prolapse for causing “unnecessary confusion and fear” in women. This is despite Brisbane gynaecologist and obstetrician Professor Chris Maher, among others, criticising the college for remaining largely silent about growing alarm over prolapse and incontinence pelvic mesh devices for a decade from 2003.
It is also despite the Australian device regulator, the Therapeutic Goods Administration, TGA, continuing to classify all pelvic mesh devices as medium to high risk.
In a paper in February Professor Maher said women questioned “the competence and trustworthiness of us as clinicians” because pelvic mesh devices were used to treat prolapse and incontinence without evidence they were safe and beneficial.
“It is imperative that pelvic floor surgeons take a leadership role that ensures the mistakes of the past are not revisited,” Professor Maher said.
The mesh is a permanent material that can result in mesh exposure and infection which may occur soon after surgery or many years later. This can result in the need for mesh removal which may be difficult, may have complications and may not completely resolve chronic pain or other adverse symptoms.RANZCOG
In its position statement RANZCOG outlined known complications of even traditional midurethral sling pelvic mesh surgery, and said surgeons “must discuss” the complications with women so they could give informed consent.
“Discussion must include bleeding, damage to the bladder and urethra, bowel and major vessel perforation and voiding difficulties which may require catheterisation, loosening or even division of the sling at a later stage,” RANZCOG said.
Midurethral sling pelvic surgery for incontinence, even using traditional slings like TVT that are regarded as the “gold standard”, could cause pain and painful sexual intercourse, RANZCOG said.
“This is usually short lived but may become intractable. In some women these long term adverse outcomes have had severe effects on everyday activities and their quality of life.
“The mesh is a permanent material that can result in mesh exposure and infection which may occur soon after surgery or many years later. This can result in the need for mesh removal which may be difficult, may have complications and may not completely resolve chronic pain or other adverse symptoms.”
Australian Pelvic Mesh Support Group founder Caz Chisholm, who successfully campaigned for a Senate inquiry into the devices that will start public hearings in the next two months, slammed RANZCOG and said all pelvic mesh devices and slings should be banned because of the severity of complications some women experienced.
A group poll of 85 members found more than half had complications from the midurethral sling, and another 20 per cent had complications from a combination of prolapse mesh and midurethral sling treatment.
If it is safe and highly effective, why do they need the trials? Why have the trials not already been done prior to implanting the midurethral sling? This means women are still guinea pigs.Australian Pelvic Mesh Support Group founder Caz Chisholm
“I believe the complication rates of the midurethral sling are higher because this mesh is now the most popular choice for surgeons because of the withdrawal of some prolapse meshes,” Ms Chisholm said.
She slammed RANZCOG for saying even the traditional “gold standard” mesh slings needed to be removed because “who and where are these full-removal surgeons and what training have they had to fully remove them?”
“Surgeons have said that full removal is not possible when it comes to the transobturator mesh, yet in the same sentence they say they can remove mesh. How about they film their evidence of removing it all and take photos as well?” Ms Chisholm said.
“Many, many women in the group are having partial removals and revision surgeries but none of their surgeons are removing their mesh.
“How can they say they are safe when they also suggest in the same position statement that they need clinical trials for outcomes?
“If it is safe and highly effective, why do they need the trials? Why have the trials not already been done prior to implanting the midurethral sling? This means women are still guinea pigs.”